Pivoting joint infusion system with steal

ABSTRACT

An infusion system for delivery of therapeutic fluids from a remote source into a patient&#39;s body. The system has an infusion assembly, a rotating pivot joint member, a fluid connector assembly, and a sealing assembly retained within the infusion assembly between the housing of the infusion assembly and the rotating pivot joint member. The seal reduces leakage of fluids. The rotating joint may be pivoted to three distinct positions to allow for emplacement on the patient, delivery of the therapeutic fluid to the patient, and protected, sealed closure of the fluid channels to avoid patient fluid backflow.

This application is a continuation application of continuation-in-partapplication Ser. No. 10/463,629, filed Jun. 17, 2003, now U.S. Pat. No.7,083,597 of U.S. patent application Ser. No. 09/896,149, filed Jun. 29,2001, now U.S. Pat. No. 6,579,267, issued Jun. 17, 2003, which claimspriority to U.S. Provisional Application No. 60/259,971, filed Jan. 5,2001, all of which are incorporated herein by reference for allpurposes.

FIELD OF THE INVENTION

The present invention relates to an improved system for subcutaneousdelivery of fluid to a patient. More particularly, the present inventionrelates to an infusion system having an improved sealing subsystemcooperating with a rotating pivot joint member that delivers the fluidfrom a remote source to a delivery cannula of the main infusion assemblyof the system.

BACKGROUND OF THE INVENTION

Prior art infusion sets or systems provide numerous ways for engaging afluid connector to a base to deliver a therapeutic fluid subcutaneouslyto a patient. Most of these prior art systems are plagued with leakingconnections and inefficient ways to allow the patient to disconnect thefluid connector from the base without a backflow of fluid from thepatient through the base and back into the environment.

The present invention provides an improved sealing subsystemincorporated into a pivoting or rotating “ball” joint that moves from anemplacement position to an infusion or delivery position to adisconnected, protected, closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of the present invention systemwith the fluid connector attached to the rotating pivot member in avertical, non-delivery position.

FIG. 2 shows the fluid connection moved to an operating, infusion ordelivery position and locked in engagement with the base unit.

FIG. 3 shows the base unit of the present invention with the rotatingpivot member in the vertical position to accept an emplacement needleassembly.

FIG. 4 is a bottom perspective view of the fluid connector of thepresent invention with a fluid delivery tube attached thereto.

FIG. 5 illustrates a partial cross sectional side elevation plan view ofthe present invention in a first emplacement position.

FIG. 6 shows the pivot member and base unit of FIG. 5 with theemplacement needle withdrawn and the rotating pivot member rotated to asecond infusion or delivery position.

FIG. 7 is an exploded perspective view of the base unit of the presentinvention showing the seal assembly and the rotating pivot member.

FIG. 8 is a detailed perspective view of the seal assembly of thepresent invention.

FIG. 9 illustrates a perspective view of the base assembly and therotating pivot member of the present invention rotated to a protectedclosed position to prevent backflow of patient fluids.

FIG. 10 shows three distinct positions of the rotating or pivotingmember of the present invention, namely, the emplacement position, theinfusion position, and the protected, closed position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE PRESENTINVENTION

FIG. 1 is a perspective view of the infusion system 10 of the presentinvention. In FIG. 1, the main infusion unit 12 is shown with the fluidconnector assembly 14 attached to the rotating pivot joint member 16.The joint member 16 is rotatably attached to the housing 17 of unit 12.The emplacement needle 18 (FIG. 5) has been withdrawn and the connectorassembly is still in an upright or vertical position. Therapeutic fluidfrom a remote source (not shown but well known in the art) such as awall or rack hung bottle or plastic fluid bag may be delivered throughdelivery tube 20 to the connector assembly 14 and into the patient.However, the preferred procedure is for the needle to be withdrawn andthe joint member 16 slightly rotated downwardly to misalign theemplacement channel 54 (FIG. 5A) and the injection channel 40. This willprevent or significantly avoid a backflow of patient fluids as will bediscussed below. The connector assembly 14 is then attached to the jointmember 16 and the rotating joint member and the connector assembly 14are to be rotated about joint member 16 to the horizontal delivery orinfusion position shown in FIG. 2. In FIG. 2, the fluid connector 14 hasrotated about joint 16 and has locked onto the locking tabs 22 (FIG. 1)of the main infusion unit 12 and is thereby held securely in place.

FIG. 3 shows a slightly modified main infusion unit 12 a having a pivotjoint member 16 a with an O-ring seal 24 on neck section 26 of thejoint. Neck 26 has opposing wings 28 which serve to ensure an alignedrotation of the joint 16 a about the housing 17 a. The wings furtherfunction to ensure proper alignment of the connector assembly 14 a tothe main infusion unit 12 a. FIG. 9 additionally shows how wings 28 holdthe neck 26 in a third distinct position. FIG. 3 also illustrates arecess section 30 and cover 32 in housing 17 a. As will be describedbelow, the recess 30 accepts the top section of neck 26 in a thirdrotated position of joint 16 a and cover 32 shields, protects, and sealsthe central fluid channel 34 in the joint member 16 a when the fluidconnector has been removed from the rotating pivot joint member 16 a.

FIG. 4 illustrates in a perspective view the underside or bottom side ofthe fluid connector 14 a which attaches at a near end 36 to the rotatingpivot joint member. It should be noted in FIG. 4 that the fluid deliverychannel 38 in connector 14 a has a slight approach angle variation aswill be described in more detail in the discussion of FIG. 10.

The structural arrangement or relationship of the joint member 16 a tohousing 17 a is seen in the partial cross sectional view of FIG. 5. FIG.5 shows the joint 16 a in a first emplacement position with anemplacement needle 18 extending through the rotating joint 16 a, throughthe injection channel 40 of cannula 42, and subcutaneously piercing theskin of the patient. A retainer plate 44 holds the cannula 18 within thehousing 17 a. The emplacement of the needle and how the main infusionunit may be affixed to the patient are well understood as described inU.S. Pat. No. 6,579,267. Also shown in FIG. 5 is the placement andretention of sealing assembly 50 within housing 17. FIG. 8 shows thesealing assembly in greater detail.

The rotating pivot joint member 16 a is shown in a side elevationalcross sectional view in FIG. 5A. Central fluid channel 34, needleemplacement channel 54, and fluid infusion channel 56 intersect in acentral portion 58 of the joint 16 a. Grooves 60 are provided for O-ringseals in the neck section.

FIG. 6 shows the pivot member or joint 16 a with the emplacement needlewithdrawn and fluid connector assembly 14 a attached. The joint 16 a isrotated to an infusion or delivery position with the infusion channel 56aligned with the injection channel 40 in cannula 42. Thus, therapeuticfluid 60 from the remote source flows through fluid delivery channel 38in connector assembly 14 a into central fluid channel 34, into infusionchannel 56 through cannula injection channel 40 into the patient. Aswould be understood by one of skill in the art, the connector assembly14 a is secured to the main infusion unit 12 a by the locking tabs 22urging against the body 15 of the connector assembly.

In FIG. 7 an exploded perspective illustration is provided of pivotjoint member 16, housing 17, sealing assembly 50, and rotating pivotjoint member receiving chamber 51. The joint 16 has axial rotationjournals or ears 72 which engage in slots 70 in the receiving chamber51. The sealing assembly also fits snugly between the housing 17 and thejoint 16 when the system is fully assembled. Turning to FIGS. 5 and 6 itmay be seen that elastomeric seal 50 is urged beneath overhanging ledge53 of housing 17 and is thereby further held in position. When the joint16 is rotatably secured in the chamber 51, the seal 50 provides asealing surface for the joint body 19 to sealingly rotate upon. In FIG.8, the L-shaped seal assembly 50 has an orifice 61 to allow the needleor fluid to pass through. A raised rib 80 along the inner surface 81 ofthe seal may be used to provide an additionally tight seal. It should beunderstood that the use of various cooperating materials may be used inthe construction of the seal 50 and the joint body 19. A hard-to-softsurface interface may be employed. The seal may be softer than the jointor vice versa. Two hard surfaces with cooperating coefficients offriction may be employed.

A protected, closed, and sealed third position of the rotating pivotjoint member 16 a is shown in FIG. 9. When the patient removes theconnector assembly 14 or 14 a from the pivot joint 16 or 16 a, thealignment of the injection channel and the infusion channel in the jointwould allow patient fluids to flow back through the infusion assemblyand leak or flow into the environment. However, a unique feature of thepresent invention allows the user to rotate the pivot joint 16 adownwardly to a third distinct position placing the neck 26 and centralfluid channel 34 into recess 30 with cover 32 sealing off the openchannel 34. Thus, no patient fluids backflow through the system. FIG. 9also illustrates that alignment wings 28 also function to stop thedownward rotation of the joint 16 a; and, because they rub or slidetightly along housing shoulder 27 of the main infusion assembly 12 a,the neck 26 is retained in the recess during the user's movement.

The distinct positions of the rotating “ball” pivot joint member 16 areillustrated in FIG. 10. In position A, the emplacement needle may beguided through the appropriate channels in the joint to allow the maininfusion unit 12 to be attached to the patient. In position B, theneedle has been removed and the fluid connector assembly 14 attached tothe joint 16. The fluid channels in the connector assembly and the jointare aligned to allow for the therapeutic fluid to flow from the remotesource through the delivery tube, through the joint and cannula channelsto the patient. In position C, the fluid connector assembly 14 has beenremoved and the joint rotated further downwardly to rest in recess 30with cover 32 sealing the fluid channel 34. Additionally, the furtherrotation of the joint misaligns the infusion channel 56 of the jointfrom the injection channel 40 of the cannula thereby further sealing offthe backflow of any patient fluids through the system to theenvironment.

It may be seen in FIG. 10 that the sealing assembly 50 directly engagesover 90° of the surface of the pivot joint 16 in any one of the distinctpositions; but, because of the rotatability of the joint, over 270° ofthe ball joint surface is sealingly urged against the seal assembly 50.This feature provides for a more efficient sealing of the channels inthe joint thereby reducing leakage problems associated with the priorart.

Although the invention has been described with reference to a specificembodiment, this description is not meant to be construed in a limitingsense. On the contrary, various modifications of the disclosedembodiments will become apparent to those skilled in the art uponreference to the description of the invention. It is thereforecontemplated that the appended claims will cover such modifications,alternatives, and equivalents that fall within the true spirit and scopeof the invention.

The invention claimed is:
 1. An infusion system for delivery of atherapeutic fluid from a remote source into a patient's body comprising;a main infusion unit having a housing, a cannula with an injectionchannel, said cannula attached at an underside of said main infusionunit, a first fluid channel in communication with said cannula, and arotating joint member receiving chamber; a rotating joint member havinga central fluid channel, a needle emplacement channel, and a fluidinfusion channel, all of said channels intersecting within a centralportion of said rotating joint member, said rotating joint memberadapted to be received within and rotatable within said chamber and; afluid connector assembly having a fluid delivery channel, said fluidconnector assembly attachable at an end of said rotating joint membersuch that said fluid delivery channel aligns with and is incommunication with said central fluid channel of said rotating jointmember, said fluid connector assembly attachable at a remote end to adelivery tube attached to said remote source of said therapeutic fluid;wherein said rotating joint member rotatable from a first emplacementposition whereby an emplacement needle may be extended through saidneedle emplacement channel of said rotating joint member and throughsaid injection channel of said cannula to subcutaneously pierce saidpatient to a second delivery position after said emplacement needle hasbeen withdrawn from said patient and said fluid connector assembly hasbeen attached at said near end of said rotating joint member, saidsecond delivery position aligning said fluid infusion channel with saidinjection channel of said cannula to deliver said therapeutic fluid tosaid patient.
 2. The infusion system of claim 1, wherein the maininfusion unit further comprises a recess in said housing to receive andretain said rotating joint member when said rotating joint member isrotated to a third position, the third position for preventing flow oftherapeutic fluid to the patient's body.
 3. The infusion system of claim2, wherein the main infusion unit further includes a cover adapted toprotect an opening to said central fluid channel in said rotating jointmember when said rotating joint member is rotated to the third position.4. The infusion system of claim 1, wherein said rotating joint memberupon removal of said fluid connector assembly is rotatable to a thirdposition, said third position misaligning said fluid infusion channelwith said first fluid channel of said main infusion unit tosubstantially prevent delivery of said therapeutic fluid to saidpatient.
 5. The infusion system of claim 4, wherein the central portionof said rotating joint member is a ball joint.
 6. The infusion system ofclaim 5, wherein said rotating joint member includes ears attached tothe ball joint.
 7. The infusion system of claim 1, further includingfluid sealing member cooperating with said fluid connector assembly andsaid rotating joint member to provide a fluid tight seal when the fluidconnector assembly is engaged with the rotating joint member.
 8. Theinfusion system of claim 1, further including means to releasably locksaid fluid connector assembly to said rotating joint member when saidfluid connector assembly is in said second delivery position.
 9. Theinfusion system of claim 1, wherein the main infusion unit has wallsdefining a cutout and the fluid connector assembly has walls dimensionedfor receipt into the cutout when the fluid connector assembly is in thesecond delivery position.
 10. The infusion system of claim 1, whereinthe main infusion unit, rotating joint member, and fluid connectorassembly are all septumless.